(77 days)
No
The summary describes a mechanical embolic protection system and does not mention any AI or ML components or functions.
Yes
The device is used as an embolic protection system during angioplasty, stenting, and atherectomy, which are medical procedures performed to treat conditions related to blood vessels. By containing and removing embolic material, it directly intervenes in a physiological process to improve health and prevent complications.
No.
Explanation: The device is an embolic protection system used to contain and remove embolic material during medical procedures. It is a therapeutic device, not one that identifies or diagnoses a condition.
No
The device description explicitly states that WIRION™ is comprised of an independent Filter Unit and is a rapid exchange system, indicating it is a physical medical device with hardware components.
Based on the provided information, the WIRION™ device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that WIRION™ is an "embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries." This describes a device used within the body during a medical procedure, not a device used to test samples outside the body.
- Device Description: The description details a physical system comprised of a "Filter Unit" delivered and deployed on guide wires. This is consistent with an interventional medical device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), performing tests on those samples, or providing diagnostic information based on such analysis.
Therefore, WIRION™ is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
Product codes
NTE
Device Description
WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid arteries and lower extremities (LE) arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical and non-clinical tests were conducted. The animal studies conducted on the cleared WIRION are applicable for the expanded indication WIRION. The following additional bench tests were conducted for the expanded indication in order to determine substantial equivalency. All tests met their predetermined acceptance criteria for its intended use.
Non-clinical Data:
The following tests have been performed:
- a) Embolic capture efficiency and retrieval ability
- b) Stent Compatibility
- Simulated use C)
Clinical Data:
Clinical data from two clinical studies were utilized to support substantial equivalency of the cleared WIRION EPS (K143570). For the purpose of the expanded WIRION substantial equivalency, a clinical study titled WISE LE: Evaluation of WIRION EPS in Lower extremities arteries was performed. The study aim was to assess safety and performance of the WIRION specific to the expanded indication i.e., the safety and performance of the system in calcified lesions of the lower extremities arteries together with the atherectomy procedure.
WISE LE clinical study:
One hundred and three (103) patients were enrolled in the study. Mean age was 68.2-9.1 and 68.9% of the patients were males. Patients are similar in baseline characteristics to the historical control population.
Primary study endpoint was freedom from major adverse events (MAE) to 30 days post procedure. MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinicallydriven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
Only two patients had MAE, as adjudicated by the independent Clinical Events Committee (CEC). As indicated in the protocol, the historic controls average MAE rate was 10.6%. From the results it is shown that the WIRION system met the primary endpoint since only 2 patients had MAE which means that MAE rate was 1.9%.
The study analysis compared the proportion of subjects experiencing MAE to the performance goal (PG). The P-value obtained (
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 21, 2018
Gardia Medical Ltd. Vardit Segal, Ph.D. VP Clinical and Regulatory Affairs 2 Ha-Eshel St. P.O. Box 3081 Caesarea Industrial Park 38900, Israel
Re: K180023
Trade/Device Name: Wirion Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: NTE Dated: December 27, 2017 Received: January 3, 2018
Dear Dr. Segal:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
Page 2 - Dr. Vardit Segal
and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K180023
Device Name
WIRION™
Indications for Use (Describe)
WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/ debris) while performing angioplasty and stenting in the carotid arteries and atherectorny in calcified lesions of the lower extremities (LE) arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
TRADITIONAL 510(K) SUMMARY WIRION™ Embolic Protection System
| Date of summary: | March 13, 2018 |
|---|---|
| 510(k) Number: | K180023 |
| Applicant's Name: | Gardia Medical Ltd. |
| 2 Ha-Eshel St. P.O. Box 3081 | |
| Caesarea Industrial Park 38900, Israel | |
| Tel.: +972-4-6277166, Ext. 107 | |
| Fax: +972-4-6277266 | |
| Contact Person: | Vardit Segal |
| VP Clinical and Regulatory Affairs | |
| Phone: (972) 4-6277166, Ext. 100 | |
| Fax: (972) -4-6277266 | |
| vardit@gardiamedical.com | |
| Trade Name: | |
| Common name: | WIRIONTM |
| Embolic Protection Device | |
| Classification: | Name: Embolic Protection System |
| Description: Cardiovascular Percutaneous catheter | |
| Product Code: NTE | |
| Regulation Number: 870.1250 | |
| Class: II | |
| Classification Panel: Cardiovascular Percutaneous catheter | |
| Predicate Devices: | Substantial equivalence to the following predicates is claimed: |
-
Primary Predicate: SpiderFX Ev3, cleared under 510(k)
number K111010. -
Reference Device: WIRIONTM Embolic Protection System;
Gardia Medical, cleared under 510(k) number K143570. |
Device Description:
WIRION™ is a embolic protection system comprised of an independent Filter Unit that can be delivered, locked and deployed on commercially marketed guide wires, according to physician preference, anywhere on the wire. The WIRION™ is a rapid exchange system for single use by a single operator. The WIRION™ is identical to the FDA cleared (K143570) WIRION device indicated for use in carotid artery stenting (CAS) procedures.
4
Indication for Use Statement:
WIRION™ is indicated for use as an embolic protection system (EPS) to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting in the carotid arteries and atherectomy in calcified lesions of the lower extremities (LE) arteries.
The diameter of the vessel at the site of filter basket placement should be between 3.5mm to 6.0mm. WIRION™ may be used with commercially available 0.014" guide wires.
Technological characteristics and Substantial Equivalence:
A comparison between the WIRION™ Embolic Protection System and its predicates (the SpiderFX cleared under K111010 and the WIRION cleared under K143570) addressed the device's intended use, system components, functional characteristics, principle of operation, technological characteristics, sterilization, materials and biocompatibility. Based on that comparison it was concluded that the WIRION™ Embolic Protection Device is substantially equivalent to the predicate devices.
Performance Testing:
Clinical and non-clinical tests were conducted. The animal studies conducted on the cleared WIRION are applicable for the expanded indication WIRION. The following additional bench tests were conducted for the expanded indication in order to determine substantial equivalency. All tests met their predetermined acceptance criteria for its intended use.
Non-clinical Data:
The following tests have been performed:
- a) Embolic capture efficiency and retrieval ability
- b) Stent Compatibility
- Simulated use C)
Clinical Data
Clinical data from two clinical studies were utilized to support substantial equivalency of the cleared WIRION EPS (K143570). For the purpose of the expanded WIRION substantial equivalency, a clinical study titled WISE LE: Evaluation of WIRION EPS in Lower extremities arteries was performed. The study aim was to assess safety and performance of the WIRION specific to the expanded indication i.e., the safety and performance of the system in calcified lesions of the lower extremities arteries together with the atherectomy procedure.
WISE LE clinical study:
One hundred and three (103) patients were enrolled in the study. Mean age was 68.2-9.1 and 68.9% of the patients were males. Patients are similar in baseline characteristics to the historical control population.
Primary study endpoint was freedom from major adverse events (MAE) to 30 days post procedure. MAE defined as a serious adverse event that results in death, acute myocardial infarction, thrombosis, pseudo-aneurysm, dissection (grade C or greater) or clinical perforation
5
at the filter location, distal embolism (clinically relevant), unplanned amputation, or clinicallydriven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).
Only two patients had MAE, as adjudicated by the independent Clinical Events Committee (CEC). As indicated in the protocol, the historic controls average MAE rate was 10.6%. From the results it is shown that the WIRION system met the primary endpoint since only 2 patients had MAE which means that MAE rate was 1.9%.
The study analysis compared the proportion of subjects experiencing MAE to the performance goal (PG). The P-value obtained (